(112 days)
Urine Chemistry Analyzer UR-50 is for use with the IND Urinalysis Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity in urine. It can be used for testing in the clinical laboratory setting. For professional use only. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Urine Chemistry Analyzer UR-50. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- The FDA's determination of substantial equivalence for the device to legally marketed predicate devices.
- Regulatory classifications and requirements.
- Contact information for further inquiries.
- The intended use of the device, as described in the "Indications for Use" section.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in a separate submission document, such as the 510(k) summary or a detailed clinical study report, which is not part of the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, with three wave-like lines below it.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 0 1 2007
IND Diagnostic Inc. c/o CITECH 5200 Butler Pike Plymouth Meeting, PA 19462 US Attn: Raylene Balard
Re: K063390
Trade/Device Name: Urine Chemistry Analyzer UR-50 Regulation Number: 21 CFR §862.1340 Regulation Name: Urinary glucose (non-quantitative) test system. Regulatory Class: Class II Product Code: JIL, JIO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB & KQO Dated: February 12, 2007 Received: February 13, 2007
Dear Ms. Balard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063390
Device Name:
Urine Chemistry Analyzer UR-50
Indications For Use:
Urine Chemistry Analyzer UR-50 is for use with the IND Urinalysis Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity in urine. It can be used for testing in the clinical laboratory setting. For professional use only.
These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carl Benson
... Sign-Off
Ce of In Vitro Diagnostic Device Chation and Safety
KC63390
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.